Dietary Allowance of Methyl Donor Nutrients to Minimize Risks of Non-alcoholic Fatty Liver Progression

NCT ID: NCT05291104

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-07-31

Brief Summary

Investigate the methyl donors requirement of NAFLD patients to correct the malnutrition, lipid-toxicity, microbiota dysfunction, and metabolomics biomarkers.

Detailed Description

Folate/choline/betaine, service as a methyl-donor nutrients, are essential nutrients involving in hepatic one-carbon and bioenergetic metabolism. Methyl-donor nutrients deficiency cause liver and muscle dysfunction as result of non-alcoholic fatty liver diseases (NAFLD) and its progressive lesions of steatohepatitis (NASH), fibrinogen cirrhosis and hepatoma. As methyl-donor nutrients intakes in Taiwanese population are highly insufficient, the dietary requirement of methyl-donor nutrients upon genetic, epigenetic and microbiota interaction to prevent or/and co-therapy of NAFLD progression is currently not known. In this study, we investigate whether intervention of methyl-donor nutrients improve or retard NAFLD progress. NAFLD patients are randomly divided into three groups and received placebo, folic acid, or choline, respectively. From first day to ten day, interventions are given double recommended daily intake dose of folic acid or double adequate Intakes dose of choline, then continuing with four times, and eight times dose for every 10 days. All supplements solve in cranberry juice. At the end of every ten days intervention prior, interventions are measurement of weight and body fat, and collection of blood and feces. The primary outcome measures are described to decreased body weight or body fat, improvement of liver function and fatty liver, and increasing methyl-donor nutrients levels.

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Interventions are not received any treatments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Interventions are received folic acid or choline

Group Type: EXPERIMENTAL

Folic acid, choline chloride

Intervention Type: DIETARY_SUPPLEMENT

In this study, we divide intervention group into two groups which received folic acid (FA) or choline chloride (CC) supplement. Each subgroups contain 20 subjects, including 10 men and women. According to Recommended Daily Nutrient Allowance, FA recommended intake is 400 ug / day and choline recommended intake in men and women is 450 and 390 mg / day. From phase 1 to phase 3 stage, for every 10 days, subjects are given 2-fold, 4-fold and 8-fold recommended intake dose of FA or CC. All supplement solve in 240 ml cranberry juice.

Interventions

Folic acid, choline chloride

In this study, we divide intervention group into two groups which received folic acid (FA) or choline chloride (CC) supplement. Each subgroups contain 20 subjects, including 10 men and women. According to Recommended Daily Nutrient Allowance, FA recommended intake is 400 ug / day and choline recommended intake in men and women is 450 and 390 mg / day. From phase 1 to phase 3 stage, for every 10 days, subjects are given 2-fold, 4-fold and 8-fold recommended intake dose of FA or CC. All supplement solve in 240 ml cranberry juice.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• NAFLD/NASH patients
• Folate levels in plasma < 6 ng/mL or choline levels in plasma < 5 micromol per liter
• Folate intake < estimated average requirement or choline intake < 50% adequate Intakes
• Homocysteine levels in plasma > 9 micromol per liter

Exclusion Criteria

• Asymptomatic carrier of hepatitis B and C
• Liver disease except NAFLD
• Taking drugs that causes fatty liver
• Inflammation about stomach or intestines
• Pregnancy
• Cancer except liver cancer
• Heart disease, vascular disease, or psychosis
• Intake alcohol over 100 g or unaccessible intake alcohol

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Jen Catholic University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rwei-Fen Syu Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu-Shun Lin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University

Locations

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

C108076

Identifier Type: -

Identifier Source: org_study_id